At the baseline visit, after having responded to the questionnaire, participants in the education arm will be given the patient educational tool.

Subjects in the standard of care arm will not receive the patient educational tool. If participants ask specific questions on pregnancy complications and/or preeclampsia, the clinicians will provide relevant information as they judge appropriate, but without handing out the patient educational tool.

Pre-Eclampsia

Pregnancy Complications

Systemic Lupus

This tool is a modified version of the patient educational sheet elaborated and validated by You et al in collaboration with the Preeclampsia Foundation. This patient educational sheet graphically defines preeclampsia and its. A licensing agreement has been obtained from the Preeclampsia Foundation, with the rights to modify the educational tool for this RCT. The SLE-specific educational tool will consist in a sheet displaying the previously developed patient educational form on the recto. However, on the verso of the sheet, SLE-specific information related to the risk of preeclampsia in SLE pregnancies and the estimated efficacy of ASA in reducing preeclampsia risk in women at high risk are displayed.

Patient Educational Tool

McGill University Health Centre

ASA Patterns for Prevention of Preeclampsia in SLE Pregnancies

Aspirin Patterns of Use and Adherence for Prevention of Preeclampsia in SLE Pregnancies

Responses to preeclampsia knowledge questionnaire will be compared at baseline (before randomization) and at second trimester. Questionnaire includes 20 questions, both closed and open ended, regarding preeclampsia implications, symptoms, role of aspirin for its prevention and actions that should be taken if patient experiences preeclampsia symptoms. The questionnaire total score ranges from 0 to 20, with higher score indicating better preeclampsia knowledge. The questionnaire will be scored by 2 independent investigators calculating the number of correct responses.
Subjects will be randomized in a 1:1 ratio to either patient educational tool or standard of care. SLE specific educational tool consists of sheet displaying the previously developed patient education form on recto. On verso SLE-specific information related to the risk of preeclampsia in SLE pregnancies and the estimated efficacy of ASA in reducing preeclampsia risk in women at high risk are displayed.

At each 4 pregnancy time points, up to and including 12 weeks gestation (baseline), between 20 - 24 weeks (2nd trimester), between 30-34 weeks (3rd trimester) and at 8 to 12 weeks after delivery, patient self-reported ASA use (i.e. current user versus non-user) will be recorded for all participants.

In participants, the Adherence to Refills and Medications Scale (ARMS) will measure changes in aspirin adherence at baseline and second trimester visit. The ARMS is a validated self-reported questionnaire developed for patients with chronic diseases with low literacy. It includes 12 short and simple questions, each scored 1 ("always") to 4 ("never"), and the total ranges from 12 to 48, with lower scores indicating higher levels of reported adherence. Investigator will define adherence as a continuous variable using the ARMS score and compare the between-group difference using a logarithmic transformation of ARMS scores at the baseline and 2rd trimester visits.

Changes in the visual analogue scale measuring ASA adherence from baseline to second trimester visit.
On a scale of 0 to 10 where 0 is never and 10 is always, patient-reported adherence to aspirin use will be measured.

Information will be kept between investigators.

Evelyne Vinet

Principal Investigator

McGill University Health Centre/Research Institute of the McGill University Health Centre

University of Calgary

University of Toronto

Dalhousie University

University of British Columbia

University of Manitoba

University Health Network, Toronto

Laval University

Granulomatosis With Polyangiitis

Microscopic Polyangiitis

Wegener's

Rare Diseases Clinical Research Consortium

nephritis/− nikotyna

ASA Patterns for Prevention of Preeclampsia in SLE Pregnancies

Longitudinal Protocol for Granulomatosis With Polyangiitis (Wegener's) and Microscopic Polyangiitis

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